Votrient (pazopanib hydrochloride) Tablets

WARNINGS AND PRECAUTIONS

Hepatic Effects

Concomitant use of VOTRIENT and simvastatin increases the risk of ALT elevations and should be undertaken with caution and close monitoring [see Drug Interactions (7.3)].

Insufficient data are available to assess the risk of concomitant administration of alternative statins and VOTRIENT

ADVERSE REACTIONS

DRUG INTERACTIONS

Effect of Concomitant use of VOTRIENT and Simvastatin

Concomitant use of Votrient and simvastatin increases the incidence of ALT elevations. Across monotherapy studies with Votrient, ALT >3 X ULN was reported in 126/895 (14%) of patients who did not use statins, compared with 11/41 (27%) of patients who had concomitant use of simvastatin. If a patient receiving concomitant simvastatin develops ALT elevations, follow dosing guidelines for Votrient or consider alternatives to Votrient. Alternatively, consider discontinuing simvastatin. Insufficient data are available to assess the risk of concomitant administration of alternative statins and Votrient.

WARNINGS AND PRECAUTIONS

Hypertension

In clinical studies, events of hypertension including hypertensive crisis have occurred... Votrient should be discontinued if there is evidence of hypertensive crisis or if hypertension is severe and persistent despite antihypertensive therapy and dose reduction of Votrient.